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Tamsulosin hydrochloride film-controlled slow-release pellet capsule

A technology for sustained-release pellets and capsules, which is applied in the field of tamsulosin hydrochloride membrane-controlled sustained-release pellets and capsules, and can solve problems such as decreased release.

Active Publication Date: 2013-07-24
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the problem of release decline caused by film aging of tamsulosin hydrochloride film-controlled sustained-release pellets prepared by water dispersion coating, the present invention provides a film capable of maintaining stable release performance throughout the effective period The controlled-type tamsulosin hydrochloride sustained-release pellet capsule is characterized in that the core of the pellet contains sodium carboxymethyl starch with high water-swellability, and the sustained-release coating film is deformed by water swelling, thereby offsetting the membrane aging

Method used

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  • Tamsulosin hydrochloride film-controlled slow-release pellet capsule
  • Tamsulosin hydrochloride film-controlled slow-release pellet capsule
  • Tamsulosin hydrochloride film-controlled slow-release pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Tamsulosin Hydrochloride Sustained Release Pellets Capsules with Common Pill Core

[0028] 1. Prescription

[0029] 1. Pill core prescription (1000 tablets)

[0030]

[0031] 2. Sustained release coating film coating liquid prescription

[0032]

[0033] 3. No. 0 stomach dissolving gelatin capsule shell 1000 capsules

[0034] 2. Preparation process:

[0035] 1. Pill core preparation process:

[0036] (1) Pass tamsulosin hydrochloride through a 60 mesh sieve;

[0037] (2) Weigh the prescribed amount of microcrystalline cellulose PH101 and lactose, and mix them evenly in a wet granulator;

[0038] (3) Add the prescription amount of tamsulosin hydrochloride to the prescription amount of polysorbate 80, add a small amount of water, and heat in a water bath to dissolve the tamsulosin hydrochloride and polysorbate 80;

[0039] (4) Pour all the above solution into a wet granulator, mix it with microcrystalline cellulose PH101 and lactose, and then add an appropriate amount of 2% so...

Embodiment 2

[0067] Example 2 Tamsulosin hydrochloride sustained-release pellet capsules containing 5% sodium carboxymethyl starch

[0068] 1. Prescription

[0069] 1. Pill core prescription (1000 tablets)

[0070]

[0071] 2. Sustained release coating film coating liquid prescription: same as Example 1

[0072] 3. No. 0 stomach dissolving gelatin capsule shell 1000 capsules

[0073] 2. Preparation process:

[0074] 1. Pill core preparation process:

[0075] (1) Pass tamsulosin hydrochloride through a 60 mesh sieve;

[0076] (2) Weigh the prescribed amount of microcrystalline cellulose PH101, sodium carboxymethyl starch, and lactose, and mix them evenly in a wet granulator;

[0077] (3) Add the prescription amount of tamsulosin hydrochloride to the prescription amount of polysorbate 80, add a small amount of water, and heat in a water bath to dissolve the tamsulosin hydrochloride and polysorbate 80;

[0078] (4) Add all the above solutions to the wet granulator, and then add an appropriate amount of 2% s...

Embodiment 3

[0097] Example 3 Tamsulosin Hydrochloride Sustained Release Pellets Capsules Containing 10% Sodium Carboxymethyl Starch

[0098] 1. Prescription

[0099] 1. Pill core prescription (1000 tablets)

[0100]

[0101] 2. Sustained release coating film coating liquid prescription: same as Example 1

[0102] 3. No. 0 stomach dissolving gelatin capsule shell 1000 capsules

[0103] 2. Preparation process:

[0104] 1. Pill core preparation process: same as in Example 2.

[0105] 2. The preparation process of the slow-release coating film coating liquid: the same as in Example 1.

[0106] 3. Coating (slow release coating film):

[0107] The pellet core is placed in a fluidized bed for coating to control the weight gain of the coating film, and the weight gain of the coating is 24.5% and 27.7%.

[0108] 4. Heat treatment: same as Example 1.

[0109] 5. Capsule filling: fill the coated pellets into capsules.

[0110] 3. Release, content determination and results

[0111] Determination method: same as Exampl...

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Abstract

The invention relates to a tamsulosin hydrochloride film-controlled slow-release pellet capsule. A slow-release film of the tamsulosin hydrochloride film-controlled slow-release pellet utilizes Eurdragit NE30D and HPMC E5 as film-formation materials. A pellet core of the tamsulosin hydrochloride film-controlled slow-release pellet contains sodium carboxymethyl starch having high expansibility, and also contains pharmaceutically-acceptable common excipients for the slow-release pellet, wherein preferably, the excipients comprise microcrystalline cellulose and lactose as fillers, and polysorbate 80 as a solubilizer; and the pellet core comprises 5 to 20wt% of sodium carboxymethyl starch. The slow-release film comprises Eurdragit NE30D, HPMC E5 and talcum powder as an antiplastering aid, wherein preferably, a ratio of Eurdragit NE30D to HPMC E5 to talcum powder is 30: 2: 4 and a film weight increasing ratio is in a range of 19 to 36%. The tamsulosin hydrochloride film-controlled slow-release pellet comprises the pellet core containing sodium carboxymethyl starch having high water expansibility and thus after absorbing water, the tamsulosin hydrochloride film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the tamsulosin hydrochloride film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

Technical field [0001] The invention relates to a tamsulosin hydrochloride film controlled sustained-release pellet capsule, in particular to a tamsulosin hydrochloride film controlled sustained-release pellet capsule containing sodium carboxymethyl starch in its core, belonging to a pharmaceutical preparation field. Background technique [0002] Tamsulosin hydrochloride is alpha 1A Receptor blockers, by selectively blocking alpha in the prostate 1A The receptor relaxes the smooth muscle of the prostate, thereby improving symptoms such as dysuria caused by benign prostatic hyperplasia, and is used to treat dysuria associated with benign prostatic hyperplasia. [0003] Tamsulosin hydrochloride is slightly soluble in water. This product was first marketed as a once-daily sustained-release capsule, which is a membrane-controlled sustained-release pellet capsule. The slow-release pellet coating film uses an organic solvent coating liquid, and the amount of organic solvent is relativel...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/18A61K47/32A61K47/34A61K47/36A61K47/38A61P13/08
Inventor 姜庆伟狄媛吕玉珠唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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